Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 21 February 2017

Indication(s)

1 INDICATIONS AND USAGE CUTIVATE® Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age and older. ( 1 ) CUTIVATE® Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older.

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Advisory information

contraindications
4 CONTRAINDICATIONS None. •None ( 4 )
Adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: •HPA Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] •Local Adverse Reactions [see Warnings and Precautions (5.2)] •Concomitant Skin Infections [see Warnings and Precautions (5.3)] The most common adverse reactions (2 %) were burning/stinging at the application site.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm®, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience: Controlled Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4 %.

These were local cutaneous reactions, usually mild and self-limiting, and consisted primarily of burning/stinging (2 %).

All other drug-related events occurred with an incidence of less than 1 %, and included were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection.

See Table 1.

The incidence of adverse reactions between the 242 pediatric subjects (age 3 months to < 17 years) and 196 adult subjects (17 years or older) was similar (4 % and 5 %, respectively).

Table 1: Adverse Reactions from Controlled Clinical Trials (n=438) ADVERSE REACTIONS CUTIVATE® Lotion VEHICLE n=221 n=217 Burning/Stinging skin 4 (2 %) 3 (1 %) Contact Dermatitis 0 1 (<1 %) Exacerbation of Atopic dermatitis 0 1 (<1 %) Folliculitis of legs 2 (<1 %) 0 Irritant

Contact Dermatitis 0 1 (<1 %) Pruritus 1 (<1 %) 1 (<1 %) Pustules on Arms 1 (<1 %) 0 Rash 1 (<1 %) 2 (<1 %) Skin Infection 0 3 (1 %) During the clinical trials, eczema herpeticum occurred in a 33-year old male patient treated with CUTIVATE® Lotion.

Table 2 summarizes all adverse events by body system that occurred in at least 1 % of patients in either the drug or vehicle group in the phase 3 controlled clinical trials.

Table 2: Adverse Events Occurring in?

1 % of Patients from Either Arm from Controlled Clinical Trials (n=438) Body System CUTIVATE ® Lotion Vehicle Lotion n=221 n=217 Any Adverse Event 77 (35 %) 82 (38 %) Skin Burning and Stinging 4 (2 %) 3 (1 %) Pruritus 3 (1 %) 5 (2 %) Rash 2 (<1 %) 3 (1 %) Skin Infection 0 3 (1 %) Ear, Nose

Throat Common Cold 9 (4 %) 5 (2 %) Ear Infection 3 (1 %) 3 (1 %) Nasal Sinus Infection 2 (<1 %) 4 (2 %) Rhinitis 1 (<1 %) 3 (1 %) Upper Respiratory Tract Infection 6 (3 %) 7 (3 %) Gastrointestinal Normal Tooth Eruption 2 (< 1 %) 3 (1 %) Diarrhea 3 (1 %) 0 Vomiting 3 (1 %) 2 (<1 %) Lower Respiratory Cough 7 (3 %) 6 (3 %) Influenza 5 (2 %) 0 Wheeze 0 3 (1 %) Neurology Headache 4 (2 %) 5 (2 %) Non-Site Specific Fever 8 (4 %) 8 (4 %) Seasonal Allergy 2 (<1 %) 3 (1 %) 6.2 Clinical Trials Experience: Pediatric Open Label Trials In an open label HPA axis suppression trial of 44 pediatric subjects (ages?3 months to?6 years) CUTIVATE® Lotion was applied twice daily (rather than the indicated dosing regimen of once daily) to at least 35 % of body surface area for 3 or 4

weeks.

Subjects whose lesions cleared after 2 or 3 weeks of treatment continued to apply CUTIVATE® Lotion for an additional week.

The overall incidence of adverse reactions was 14 %.

These were local, cutaneous reactions and included dry skin (7 %), stinging at application site (5 %), and excoriation (2 %).

Additionally, a 4-month-old patient treated with CUTIVATE® Lotion had marked elevations of the hepatic enzymes AST and ALT. [See Use in Specific Populations (8.4)] In another open label HPA axis suppression trial in which CUTIVATE® Lotion was also applied twice daily (rather than the indicated dosing regimen of once daily), 56 pediatric subjects (ages?3 months to 12 months), were enrolled [see Use in Specific Populations (8.4)].

The adverse reactions included 2 cases of Herpes simplex at the application site (3.6 %) and 3 cases of bacterial skin infections (5.4 %).

6.3 Postmarketing Experience The following local adverse reactions have been identified during post-approval use of CUTIVATE® Lotion: erythema, edema/swelling, and bleeding.

The following systemic adverse reactions have been identified during post-approval use of CUTIVATE® Cream and CUTIVATE® Ointment: immunosuppression/Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following local adverse reactions have also been reported with the use of topical corticosteroids, and they may occur more frequently with the use of occlusive dressings or higher potency corticosteroids.

These reactions include: acneiform eruptions, hypopigmentation, perioral dermatitis, skin atrophy, striae, hypertrichosis and miliaria.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION •Apply a thin film to the affected skin areas once daily.

Rub in gently.

(2) •Discontinue use when control is achieved.

(2) •Reassess diagnosis if no improvement in 2 weeks.

(2) •The safety and efficacy of CUTIVATE® Lotion have not been established beyond four weeks of use.

(2) •Avoid use under occlusion or application to diaper area.

(2) •Not for ophthalmic, oral, or intravaginal use.

(2) Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily.

Rub in gently.

Discontinue use when control is achieved.

If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

The safety and efficacy of CUTIVATE® Lotion have not been established beyond 4 weeks of use.

Avoid use with occlusive dressings or application to the diaper area [see Warnings and Precautions (5.1) and (5.2)].

CUTIVATE® Lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use.

Use in special populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.

Therefore, CUTIVATE® Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemic embryofetal development studies were conducted in mice, rats and rabbits.

Subcutaneous doses of 15, 45 and 150?g/ kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15.

A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150?g/ kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.

No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15?g/ kg/day (less than the MRHD in adults based on body surface area comparisons).

Subcutaneous doses of 10, 30 and 100?

g/ kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 to 15 and the other study from gestation days 7 to 17).

In the presence of maternal toxicity, fetal effects noted at 100?g/ kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification.

No treatment related effects on embryofetal toxicity or teratogenicity were noted at 10?g/ kg/day (less than the MRHD in adults based on body surface area comparisons).

Subcutaneous doses of 0.08, 0.57 and 4?g/ kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 to 18.

Fetal effects noted at 4?g/ kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification.

No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57?g/ kg/day (less than the MRHD in adults based on body surface area comparisons).

Oral doses of 3, 30 and 300?g/ kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 to 20.

No fetal or teratogenic effects were noted at oral doses up to 300?g/ kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.

However, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration.

Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100?g/ kg tritiated fluticasone propionate to pregnant rats.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when CUTIVATE® Lotion is administered to a nursing woman.

8.4 Pediatric Use CUTIVATE® Lotion may be used in pediatric patients as young as 3 months of age.

The safety and effectiveness of CUTIVATE® Lotion in pediatric patients below 3 months of age have not been established.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs.

They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see Warnings and Precautions (5.1)].

In an HPA axis suppression trial, none of the 40 evaluable pediatric subjects, 4 months old to < 6 years old, with moderate to severe atopic dermatitis covering?

35 % Body Surface Area (BSA) who were treated with an exaggerated dosing regimen (twice daily) of CUTIVATE® Lotion experienced adrenal suppression (defined as a 30-minute post-stimulation cortisol level?18 micrograms/dL) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

In another HPA axis suppression trial, one of 49 (2 %) evaluable pediatric subjects, 3 months to 11 months old, with moderate to severe atopic dermatitis covering?

35 % Body Surface Area (BSA) who applied an exaggerated dosing regimen (twice daily) of CUTIVATE® Lotion experienced reversible adrenal suppression (defined as a 30-minute post-stimulation cortisol level?18 micrograms/dL) following 4 weeks of therapy [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

Systemic effects such as Cushing 's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high-potency topical corticosteroids, or concomitant use of more than one corticosteroid product.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis unless directed by a physician.

CUTIVATE® Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.

8.5 Geriatric Use A limited number of patients above 65 years of age have been treated with CUTIVATE® Lotion in US and non-US clinical trials.

Specifically only 8 patients above 65 years of age were treated with CUTIVATE® Lotion in controlled clinical trials.

The number of patients is too small to permit separate analyses of efficacy and safety.

Pregnancy and lactation

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when CUTIVATE® Lotion is administered to a nursing woman.

More information

Category Value
Authorisation number NDA021152
Orphan designation No
Product NDC 10337-434
Date Last Revised 15-07-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 895990
Storage and handling Store between 15° and 30°C (59° and 86° F). Do not refrigerate, and keep container tightly closed.
Marketing authorisation holder PharmaDerm a division of Fougera Pharmaceuticals Inc.